About
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Secretariat: ANSI
Committee Manager: -
Chairperson (until end 2024):Akito Ohmura
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ISO Technical Programme Manager [TPM]:ISO Editorial Manager [EM]:
- Creation date: 1982
Scope
Standardisation of the particular requirements for basic safety and essential performance of medical devices and their accessories intended for ventilatory support, delivery of respiratory gases and related monitoring of patients. This includes dosing and conditioning of the gases supplied to or inhaled by the patient. These medical devices can be intended for use in specific, particular or defined healthcare environments, including home healthcare environments. These medical devices are generally active, reusable electromedical equipment (i.e. durable) with accessories that mainly are for single-patient use. ISO/TC 121/SC 3 is also responsible for the biological evaluation of gas pathways in all environments. Further, ISO/TC 121/SC 3, in co-operation with IEC/TC 62 Subcommittees utilizing Joint Working Groups, is responsible for the standardisation of the horizontal requirements for basic safety and essential performance of medical electrical equipment used in:
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This committee contributes with 42 standards to the following Sustainable Development Goals:
Liaison Committees to ISO/TC 121/SC 3
The committees below can access the documents of ISO/TC 121/SC 3:
| Reference | Title | ISO/IEC |
|---|---|---|
| IEC/SC 62D | Particular medical equipment, software, and systems | IEC |
| ISO/TC 121/SC 2 | Airway devices and related equipment | ISO |
| ISO/TC 194 | Biological and clinical evaluation of medical devices | ISO |
Liaison Committees from ISO/TC 121/SC 3
ISO/TC 121/SC 3 can access the documents of the committees below:
| Reference | Title | ISO/IEC |
|---|---|---|
| ISO/TC 121/SC 1 | Breathing attachments and anaesthetic machines | ISO |
| ISO/TC 121/SC 4 | Vocabulary and semantics | ISO |
| ISO/TC 121/SC 6 | Medical gas supply systems | ISO |
| ISO/TC 121/SC 8 | Suction devices | ISO |
Organizations in liaison (Category A and B)
| Acronym | Title | Category |
|---|---|---|
| EC - European Commission | European Commission | A |
Organizations in liaison (Category C)
C liaisons participate at the level of a Working Group
| Acronym | Title | Category |
|---|---|---|
| EIGA | European Industrial Gases Association | C |
| IEEE | Institute of Electrical and Electronics Engineers, Inc | C |
ISO/TC 121/SC 3 - Secretariat
ANSI [United States]
Arlington 22203 VA
United States
ISO/TC 121/SC 3 in the news
